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Clinical trials, a type of research that studies the safety and efficacy of potential therapeutics in people, must be conducted before bringing new medicines to patients. The U.S. Food and Drug Administration (FDA) and other global healthcare regulatory agencies review preclinical data on investigational medicines before clinical trials may start. Clinical trials would not be possible without the collaboration of the people living with the cancers we aim to treat, healthcare professionals, and advocacy groups.

Crescent Biopharma is conducting ASCEND, a Phase 1/2 clinical trial for adults with certain types of cancer

ASCEND is a clinical trial for adults (18 years or older) with advanced cancer, including cancer that has spread to other parts of the body (metastatic). 
It is assessing the safety, tolerability, and preliminary effectiveness of an investigational therapy called CR-001. Types of cancer being studied include:

  • Liver (hepatocellular carcinoma [HCC])
  • Bile duct (cholangiocarcinoma)
  • Uterine (endometrial carcinoma)
  • Stomach (gastric or gastroesophageal junction carcinoma)
  • Colorectal (colon or rectal carcinoma)
  • Lung (non-small cell lung cancer [NSCLC])
  • Cervical
  • Ovarian
What is CR-001?

CR-001 is an investigational immunotherapy targeting PD-1 and VEGF in a “bispecific antibody” design developed to fight cancer in multiple ways. It works by:

Helping the body’s immune system find and attack cancer cells by blocking PD-1, a protein tumors use to hide from immune defenses

Changing the tumor environment and slowing tumor growth by blocking VEGF, which not only reduces blood vessel formation but may also help activate additional immune defenses against the cancer

By targeting these pathways at the same time, CR-001 may help the immune system recognize and attack tumor cells, while also cutting off the tumor’s blood supply. CR-001 may also be able to concentrate in the tumor area, potentially reducing side effects in healthy tissue. In preclinical studies, CR-001 demonstrated robust antitumor effects.  

You may be able to join ASCEND if you:
  • Are 18 years or older
  • Have one of the types of cancer being studied (liver, bile duct, uterine, cervical, ovarian, stomach, colorectal, or lung) and it has progressed or spread
  • Meet all eligibility criteria for the study. The study staff will help you determine if you are eligible to participate
What’s involved in participation?

All participants will undergo a screening period, a treatment period of up to 2 years, a safety follow-up period, and long-term efficacy and survival follow-up. Participation is voluntary. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, pharmacokinetic, and pharmacodynamic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.

What is the cost to participate?
Participants in the study will receive the study medicine, as well as study-related visits, tests, and assessments at no cost. Participants may also be reimbursed for some study-related expenses, such as costs associated with travel.
Where are the study sites located?

ASCEND is a global trial and currently enrolling sites can be found at www.clinicaltrials.gov (identifier: NCT07335497).

For more information

To learn more visit https://clinicaltrials.gov/study/NCT07335497 or email

Thank you for your interest in this important study!

CR-001 is an investigational drug and is not approved by any health authority.

Expanded Access Policy

Crescent Biopharma, Inc. is a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients. We are committed to conducting clinical trials to evaluate the safety and efficacy of our investigational therapies. These trials are essential to obtaining the required marketing approvals that enable physicians to prescribe these therapies and support broad patient access.

In some circumstances, a treating physician may make a request to provide an unapproved therapy to a qualifying individual, which must be approved by the U.S. Food and Drug Administration (FDA) and supported by the pharmaceutical manufacturer. This is called an expanded access program (EAP), sometimes known as “compassionate use,” and refers to a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational therapy outside of a clinical trial when there is no comparable or satisfactory therapy available.

We currently have investigational therapies in our pipeline for the treatment of cancer. While we understand that some patients may wish to access our unapproved investigational therapies, our goal is to provide access to our therapies at the appropriate time and in a manner that is most beneficial to the relevant patient population. At this stage of our development, Crescent does not currently offer an expanded access program. We believe enrollment in our ongoing clinical trials is the safest and most effective way of obtaining access to Crescent’s investigational therapies and we encourage all patients and physicians who are interested in accessing our investigational therapies to visit the clinicaltrials.gov website to find out about enrolling.

Crescent may revise this expanded access policy at any time. Additionally, the posting of this policy by Crescent does not serve as a guarantee of access to any specific investigational new drug by any individual patient.

If you have any questions, please reach out to us at clinicaltrials@crescentbiopharma.com.